A majority of Americans would not take an H1N1 flu vaccine or
drug additive authorized for emergency use by the Food and Drug
Administration, according to a University of Pittsburgh Graduate
School of Public Health and University of Georgia study. The study,
available online today in Biosecurity and Bioterrorism: Biodefense
Strategy, Practice, and Science, found that fewer than 10 percent
of those surveyed said they would be willing to take such a vaccine
or drug and nearly 30 percent remained undecided.

The passage of the Project Bioshield Act in 2004 created the
emergency use authorization (EUA) giving the FDA the ability to
use experimental or "off label" drugs in the event of
an actual or potential emergency. To date, four vaccines against
H1N1 virus have been approved under the same process used by the
FDA for the seasonal flu vaccine. Also, several drug additives,
or adjuvants  sometimes added to vaccines to strengthen
the immune response and stretch the quantity of available vaccines
in the event of a pandemic  have been ordered and stockpiled
by the federal government in case they may be needed. But adding
them to H1N1 vaccines would trigger an EUA, which is one of the
reasons the federal government has chosen not to use them.

"Although the U.S government has held off on including an
adjuvant in H1N1 vaccines for now, American officials may need
to reconsider this decision as the pandemic unfolds," said
study author Sandra Quinn, Ph.D., associate dean for Student Affairs
and Education and associate professor at the University of Pittsburgh
Graduate School of Public Health. "There also remains a significant
shortage of the vaccines in many countries around the world. Given
this, our finding that few people would accept a new but not yet
fully approved H1N1 vaccine or drug is very worrisome," she
said.

The study was based on a survey that focused on attitudes toward
H1N1 and willingness to accept flu vaccines and drugs not officially
approved by the FDA, but authorized for emergency use. Of the
1,543 adults questioned in June 2009, 46 percent of people surveyed
said they were concerned about getting swine flu. However, nearly
86 percent said they thought it was unlikely or very unlikely
that they themselves would become ill.

Researchers also report that 63 percent of people surveyed said
they would not be willing to take "a new, but not yet approved
vaccine", and 50 percent said they would be very or extremely
worried about taking it. Of those who reported they would be moderately
to extremely worried, 70 percent said they would refuse the vaccine
outright. Only 4 percent of the most worried said they would take
the vaccine, compared to 23 percent of those who were not at all
or slightly worried.

In addition, 65 percent of those who said they would refuse the
vaccine reported being confident about their decision, compared
to only 46 percent of those who said they would take the vaccine.

Race also was associated with refusal to take the vaccine 
66 percent of whites and 60 percent of blacks reported they would
refuse the vaccine, compared to 47 percent of Hispanics. Blacks
reported they were the most worried (62 percent), followed by
Hispanics (52 percent) and whites (46 percent).

According to Dr. Quinn, these results differ from some current
opinion polls on public acceptance of an H1N1 vaccine because
the researchers explicitly asked about vaccines approved under
the EUA designation.

"Communication about the H1N1 vaccine is enormously challenging,"
said Dr. Quinn. "The additional issue of emergency use designation
would further complicate challenges to clear communication. In
the event an emergency-use adjuvant is required to stem the H1N1
pandemic, public health professionals will need to articulate
a strong case for the vaccine and aggressively address myths and
misinformation to increase understanding and acceptance."

The potential challenge in communicating with the public about
emergency use authorization is relevant beyond the question of
the H1N1 vaccine, added Dr. Quinn. "EUAs are an important
tool for the protection of the public's health in an emergency.
It would behoove public health agencies to begin now to think
about communication and education of the public on this issue."